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Preparation method of levamlodipine and olmesartan medoxomil tablet

A technology of levamlodipine and olmesartan medoxomil is applied in the field of preparation of compound oral tablet, and can solve problems such as weak hygroscopicity and instability

Inactive Publication Date: 2011-04-27
北京迈劲医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Its stability test shows that its hygroscopicity is not strong, but it is unstable in high humidity conditions, especially in humid and hot conditions.

Method used

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  • Preparation method of levamlodipine and olmesartan medoxomil tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 9

[0043] Embodiment 9 The main index investigation result of the product that embodiment 2 four kinds of preparation methods make

[0044]

Embodiment 10

[0045] Example 10 Example 1~Example 8 uses method 3 to make the main quality investigation of the product

Embodiment 11

[0046] Example 11 Example 1~Example 8 uses the preparation method 3 to make the product to accelerate the stability investigation result of 6 months * The table data in embodiment 10 is the data of 0 months.

[0047] Accelerated test conditions: 40°C, relative humidity 75% It can be seen from the test results that the tablets prepared by the non-wet granulation method have good stability, and all the indicators have no obvious changes compared with the 0 month, showing stability, and accelerating the depletion of the related substances of the two ingredients in the tablet after 6 months. Compared with the related substances of the two raw materials, there is little change.

[0048] * The content, dissolution rate and related substances of Examples 9 to 11 were all determined by liquid chromatography. In the table, levamlodipine is replaced by 1, and olmesartan medoxomil is replaced by 2; the difference in tablet weight is the relative standard deviation of 20 tablets, an...

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Abstract

The invention relates to a preparation method of a compound tablet prepared from levamlodipine and olmesartan medoxomil as well as auxiliary materials. The preparation method is characterized in that the compound tablet is prepared by adopting a mode of non-wet granulation and has better quality and stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a preparation method of a compound oral tablet composed of levamlodipine and olmesartan medoxomil. Background technique [0002] Olmesartan medoxomil (Olmesartan medoxomil) is a new angiotensin II receptor antagonist (ARB), its chemical name is 2,3-dihydroxy-2-butenyl-4-(1-hydroxy-1 -Methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-phenyl)benzyl]imidazole-5-carboxylic acid, ring 2,3-carbonate, the structural formula is as follows . [0003] Olmesartan is manufactured and supplied in ester form. Its stability test shows that its moisture-absorbing property is not strong, but it is unstable in high humidity conditions, especially in humid and hot conditions. The tablet needs to be added with a desiccant in the packaging, and as the humidity increases, the related substances increase and the content decreases. [0004] Levamlodipine (levamlodipine) is a long-acting dihydrop...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/4178A61K9/20A61K9/28A61P9/12
Inventor 马超
Owner 北京迈劲医药科技有限公司
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